Ciprofloxacin vs Placebo in Non Cystic Fibrosis Bronchiectasis
Research type
Research Study
Full title
An International, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis
IRAS ID
27820
Contact name
Diana Bilton
Sponsor organisation
Aradigm Corporation
Eudract number
2009-014412-35
Clinicaltrials.gov Identifier
Research summary
Bronchiectasis is a disease of the lungs whereby the airways are dilated and damaged. The initial cause of bronchiectasis varies (e.g. Cystic Fibrosis and previous lung infections like tuberculosis); and the continuation and worsening of the condition is the result of persistent or recurrent bouts of bacterial infections that induces a continual inflammatory response (the body??s immune reaction to infection that causes swelling and tenderness). This leads to a restriction of airflow and reduced lung function. Consequently, individuals produce increased amounts of sputum (mucus), suffer from cough, wheezing and breathlessness. There are a number of different types of bacteria that commonly infect people with bronchiectasis but one of the most problematic is Pseudomonas aeruginosa. This chronic bacterial infection is associated with poor quality of life and causes the greatest decline in lung function over time. The common treatment of worsening of these persistent/recurrent lung infections has been the use of oral or intravenous (via the blood/vein) antibiotics. New medications like inhaled antibiotics are an attractive alternative to oral or intravenous antibiotic treatments as high concentrations of the antibiotic is directly delivered to the site of infection which reduces the overall amount of antibiotic used and should lead to less side effects associated with antibiotics.This study, sponsored by Aradigm Corporation, aims to evaluate the effectiveness and safety of two different strengths of the inhaled antibiotic ciprofloxacin compared to an inhaled placebo (a dummy drug that has no therapeutic effect) in the treatment of Pseudomonas aeruginosa infection in participants with non cystic fibrosis bronchiectasis. Patients will be randomly (like tossing a coin) allocated to one of the following treatment groups in ratio of 2:2:1:1. ?½ Ciprofloxacin 100 mg in 2 mL ?½ Ciprofloxacin 150 mg in 3 mL ?½ Placebo 2 mL ?½ Placebo 3 mL Neither the participant nor the study doctor will know which treatment they will get, which will administered once-a-day by nebuliser (a device used to administer medication). This trial will enrol approximately 96 participants from 30 sites worldwide.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
09/H0304/87
Date of REC Opinion
23 Feb 2010
REC opinion
Further Information Favourable Opinion